BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SIMON BREAST LESION LOCALIZATION NEEDLE

    K Number: K914941 · Decision May 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    236
    Registration Numbers
    236
    Same Product Code
    27
    Applicant Total
    39
    Review Days
    192

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    Basic Information

    Device Name
    SIMON BREAST LESION LOCALIZATION NEEDLE
    K Number
    K914941
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Manan Medical Products, Inc.
    Date Received
    November 4, 1991
    Decision Date
    May 14, 1992
    Product Code
    GDF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GDF Guide, Needle, Surgical

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